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泡沫硬化剂治疗大隐静脉:随机对照试验,伴有或不伴有压缩治疗。

Foam sclerotherapy of the saphenous veins: randomised controlled trial with or without compression.

机构信息

Saint Martin Private Hospital, Department of Vascular Medicine, 18 rue des Roquemonts, Caen, France.

出版信息

Eur J Vasc Endovasc Surg. 2010 Apr;39(4):500-7. doi: 10.1016/j.ejvs.2009.11.027. Epub 2010 Jan 25.

DOI:10.1016/j.ejvs.2009.11.027
PMID:20097585
Abstract

OBJECTIVES

This study aims to compare the efficacy and side effects of foam sclerotherapy of the saphenous veins with or without post-treatment compression using graduated elastic stockings.

DESIGN

This is a prospective open randomised controlled trial conducted in two centres.

PATIENTS AND METHODS

Sixty patients with incompetent great (GSV) or small saphenous veins (SSV) underwent ultrasound-guided foam sclerotherapy. Randomisation was conducted immediately after sclerotherapy to two parallel groups, one (CG) with compression stockings (15-20 mmHg worn during the day, for 3 weeks) and the other (WCG) without compression. Efficacy of sclerotherapy and all of the side effects were assessed, including side effects in the treated region. On days 14 and 28, clinical and duplex ultrasound (DUS) assessments were performed by independent experts. Patients also completed quality of life (QOL), symptom questionnaires and provided satisfaction scores.

RESULTS

Five men and 55 women ranging in age from 32 to 78 (mean 57 years) years were included: 29 in the WCG and 31 in the CG group. On day 28, abolition of venous reflux and occlusion of the vein was obtained in 100% of the cases in both groups. The length of the occluded vein was the same in both groups (mean 36 cm for the GSV and 30 cm for the SSV) as was the mean diameter of the occluded vein (5 mm). Symptoms and QOL questionnaires showed equivalent improvement in both groups on day 28 compared to pre-treatment assessments. Side effects were few with no statistical difference between the two groups. Patient satisfaction scores were high in both groups for the outcome of sclerotherapy results, and good or very good for compression in 50% of the CG cases.

CONCLUSION

We found no difference between compression and control groups when comparing efficacy, side effects, satisfaction scores, symptoms and QOL. Further studies are required to establish the role of compression in sclerotherapy and to evaluate other compression strategies.

摘要

目的

本研究旨在比较泡沫硬化疗法联合和不联合术后循序减压弹力袜压迫治疗大隐静脉(GSV)和小隐静脉(SSV)反流的疗效和副作用。

设计

这是一项在两个中心进行的前瞻性、开放、随机对照试验。

患者和方法

60 名有症状的大隐或小隐静脉曲张患者接受超声引导下泡沫硬化剂治疗。治疗后立即进行随机分组,一组(CG)使用压力袜(白天穿 15-20mmHg,持续 3 周),另一组(WCG)不使用压力袜。评估硬化治疗的疗效和所有副作用,包括治疗部位的副作用。在第 14 天和第 28 天,由独立专家进行临床和双功能超声(DUS)评估。患者还完成了生活质量(QOL)、症状问卷并提供满意度评分。

结果

共纳入 5 名男性和 55 名女性,年龄 32-78 岁(平均 57 岁):WCG 组 29 例,CG 组 31 例。第 28 天,两组均 100%获得静脉反流消除和静脉闭塞。两组闭塞静脉的长度相同(GSV 为 36cm,SSV 为 30cm),闭塞静脉的平均直径也相同(5mm)。与治疗前相比,两组在第 28 天的症状和 QOL 问卷均显示出同等程度的改善。两组的副作用均较少,无统计学差异。两组患者对硬化治疗结果的满意度评分均较高,对 CG 组 50%患者的压迫治疗结果评价为好或非常好。

结论

我们发现,在比较疗效、副作用、满意度评分、症状和 QOL 时,加压组和对照组之间没有差异。需要进一步的研究来确定压迫在硬化治疗中的作用,并评估其他压迫策略。

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